Job Description Perform assigned activities to support monitoring of investigator sites and trial execution within the CPO under the supervision of Manager Clinical Development Your Responsibilities :
Act as monitor of specific sites on a clinical study, under supervision, as appropriate.
Facilitate preparation and collection of site level documents.
Participate in trial site training activities, as assigned.
Perform monitoring visits according to monitoring plan, as assigned, including source document verification.
Facilitate site drug supply management.
Co-ordinate site level updates of technical systems (ClinAdmin, EDC).
Ensure site activities in line with milestones (i.e. startup, recruitment, closeout, etc).
Demonstrate and apply GCP and ICH requirements.
Prepare study monitoring reports under supervision, as appropriate.
Assist with data query resolution process (both at Site and in-house with Data Management).
Perform Site Closeout activities.
Under the guidance of Senior CRA / CRA Group Head perform IM related activities like logistics, preparation of IM binders and technical presentations.
Assist with preparation of required regulatory submission liaising with DRA team. Minimum requirements What you’ll bring to the role :
Education in a health care or scientific discipline, a nursing qualification or relevant experience working within the CPO Medical, Safety, or QA department.
Fluent English (oral and written)
Demonstrates ability to coordinate, organize and communicate
Basic understanding of clinical development process including GCP and ICH fundamentals.
Proven ability to work in teams and deliver on commitments.
Level of proficiency in adequacy with the CRA I competency profile. Why consider Novartis? 750 million. That’s how many lives our products touch.
And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this : how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment.
Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.